Events

Recall of REVOLUTION XR/D DIGITAL RADIOGRAPHIC IMAGING SYSTEM WITH TOMOSYNTHESIS

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by GE Medical Systems, LLC.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    52010
  • Event Risk Class
    Class 2
  • Event Number
    Z-0528-2010
  • Event Initiated Date
    2009-08-13
  • Event Date Posted
    2009-12-16
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-05-24
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=81888
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    System, x-ray, stationary - Product Code KPR
  • Reason
    Certain ge radiographic fixed x-ray tables (proteus xr/a, revolution xr/d, and definium 8000) were found to have tabletops that move unexpectedly in a bi-directional mode. in rare cases, a malfunction may occur, which could result in the tabletop brakes falling to engage when the control foot pedal is released to lock the floating tabletop in place.
  • Action
    A GE Healthcare "Urgent Medical Device Correction" letter dated April 9, 2009 was issued to customers. The letter was addressed to Hospital Administrators/Managers of Radiology and Radiologists. The letter described the Product Issue, Affected Product, Safety Instructions, Product Correction and Contact Information. Operators should verify that the tabletop is locked before the patient is loaded on or off the table. A Field Modification will be performed on the affected products. A GE Healthcare Field Engineer will schedule a field visit to make this modification. Direct questions or concerns regarding the recall to your local GE Healthcare service representative or by calling 1-262-853-7685.

Device

REVOLUTION XR/D DIGITAL RADIOGRAPHIC IMAGING SYSTEM WITH TOMOSYNTHESIS
  • Model / Serial
    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and 00000062192HL0.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- UNITED STATES (including Puerto Rico), VIETNAM, VENEZUELA, URUGUAY, UNITED KINGDOM, UNITED ARAB EMIRATES, UKRAINE, TURKS AND CAICOS ISLANDS, TURKEY, TUNISIA, TRINIDAD AND TOBAGO, THAILAND, TAIWAN, SWITZERLAND, SWEDEN SPAIN, SOUTH AFRICA, SLOVENIA, SLOVAKIA, SINGAPORE, SAUDI ARABIA, RUSSIA, PORTUGAL POLAND, PANAMA, PAKISTAN, NORWAY NEW ZEALAND, NETHERLANDS , MEXICO MARTINIQUE, MALTA, MALAYSIA, LITHUANIA, LABA NON, LATVIA, KUWAIT, REPUBLIC OF KOREA, KAZAKSTAN, JORDAN, JAPAN, JAMAICA, ITALY, ISRAEL, IRELAND, INDONESIA, INDIA, ICELAND, HUNGARY, HONG KONG, GUAM, GREECE, GERMANY, FRENCH POLYNESIA, FRANCE FINLAND , ECUADOR, DENMARK CZECH REPUBLIC, CROATIA, COLUMBIAN, CHINA, CHILE , CANDA, BULGARIA, BRAZIL, BOSNIA, BELGIUM AUSTRIA, AUSTRALIA, and ARGENTINA.
  • Product Description
    GE Healthcare Definium 8000.Model # 5131070. || GE Healthcare, 3000 North Grandview, Waukesha, WI 53188. || The Revolution XR/d with Tomosynthesis is intended for use in generating Tomographic Images of human anatomy.The device is not intended for mammographic applications.
  • Manufacturer
    GE Medical Systems, LLC

Manufacturer

GE Medical Systems, LLC
  • Manufacturer Address
    GE Medical Systems, LLC, 3000 N Grandview Blvd, Waukesha WI 53188-1615
  • Manufacturer Parent Company (2017)
    General Electric Company
  • Source
    USFDA